Continuous Glucose Sensing at the Site of Subcutaneous Insulin Administration

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The study seeks to evaluate a novel treatment approach for performing continuous real-time glucose sensing and insulin delivery at the same subcutaneous tissue site.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Graz
• Collaborator: European Commission
• Treatments: Insulin; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

• 18 to 65 years of age, both inclusive

• Type 1 diabetes treated with Continuous Subcutaneous Insulin Infusion (CSII)

• HbA1C < 10%

• Signed informed consent before any study-related activities

Exclusion Criteria:

• Severe acute diseases

• Clinically overt diabetic complications

• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation

• Taking of any vasoactive substances or anticoagulation medication

• Diseases of the skin which could interfere with application of the catheters and Sensors as judged by the investigator

• Pregnancy, breastfeeding, intention of becoming pregnant or not using adequate contraception.

• Increased tendency towards development of hypoglycaemia

• Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

• Concurrent participation in another study